MAUDE Adverse Event Report: SYNTHES BETTLACH HELICAL BLADE/SCREW COUPLING SCREW; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.037.026

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: feb 16, 2015.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported that during a left trochanteric femoral nail-advanced (tfna) procedure on (b)(6) 2016, the helical blade/screw coupling screw would not go into the screw inserter while attempting to implant the lag screw.Another tfna set was readily available and new instrumentation was taken from that set to complete the procedure successfully with a delay of approximately five (5) minutes and no harm to patient.Concomitant devices reported: lag screw (part number 04.038.095s, lot 9848054, quantity 1).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

A product development investigation was performed.The returned coupling screw is unable to fully mate with the returned inserter.The coupling screw is only able to progress approximately 345mm into the inserter.The proximal end of the inserter is damaged where the coupling screw is inserted.The distal tip of the inserter is also gouged and there are two small cuts in the blue handle of the inserter.Both devices have surface wear which does not impact functionality.A visual inspection, drawing review and device history record (dhr) review were performed as part of this investigation.The complaint is confirmed and replicated.Use of the returned devices is outlined in the tfnadvanced proximal femoral nailing system screw only - technique guide.Relevant drawings were reviewed during investigation.The diameter of the coupling screw was measured to be within specification.The inner diameter of the proximal end of the inserter was measured to be within specification.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The damaged proximal end of the inserter caused the connecting screw to be unable to mate; it is unknown how the inserter became damaged.There were no issues during the manufacture of this product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HELICAL BLADE/SCREW COUPLING SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6244707
• MDR Text Key: 64606547
• Report Number: 9612488-2017-10020
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070425
• UDI-Public: (01)10886982070425(10)9375197
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.026
• Device Lot Number: 9375197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 04.038.095S, TFNA SCREW 95MM ¿ STERILE, QTY 1
• Patient Age: 69 YR